Recall Z-2117-2014— Dynarex Corporation
Class II · Terminated
Class II FDA medical device recall by Dynarex Corporation, initiated 2014-07-02, terminated 2017-04-20. It names one FDA 510(k) clearance: K052743. Product: CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.. Reason: "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers..
- Recalling firm
- Dynarex Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-02
- Terminated
- 2017-04-20
- Firm location
- Orangeburg, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
Reason for recall
"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.